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Exemption from Substantial Equivalence

 


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Overview of Exemption Requests (EX REQ)

An EX REQ can be submitted by the original manufacturer for any new tobacco product seeking an FDA exemption order, under section 905 (j)(3) of the Federal Food, Drug, and Cosmetic (FD&C) Act.  A new tobacco product may be considered for an exemption from Substantial Equivalence (SE) if FDA determines that:

  • The new tobacco product is modified by adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive; 
  • The proposed modification is minor and to a legally marketed tobacco product;
  • An SE Report is not necessary; and
  • An exemption is otherwise appropriate

Preparing an EX REQ (step 1) and Abbreviated Report (step 2)

Step 1: Prepare an EX REQ

  • An EX REQ includes (as required by 21 CFR 1107.1): 
    • The manufacturer's address and contact information
    • Identification of the tobacco product
    • A detailed explanation of the purpose of the modification
    • A detailed description of the modification, including a statement as to whether the modification involves:
      • adding a tobacco additive; 
      • deleting a tobacco additive;
      • increasing the quantity of an existing tobacco additive; or
      • decreasing the quantity of an existing tobacco additive
    • A detailed explanation of why the modification is a minor modification of a tobacco product that can already be sold under the FD&C Act.
    • A detailed explanation of why an SE Report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health.
    • A certification signed by a responsible official of the manufacturer summarizing the supporting evidence and providing the rationale for the official’s determination that the modification does not increase the tobacco product’s: 
      • appeal to or use by minors; 
      • toxicity; 
      • addictiveness; or 
      • abuse liability
    • Other information justifying an exemption
    • An environmental assessment prepared in accordance with the requirements of § 25.40
    • Submission in electronic format (unless previous waiver was granted)
    • Additional applicable required items per the final rule Refuse to Accept Procedures for Premarket Tobacco Submissions
  • We recommend the following structure:
    • Cover letter and Administrative Information
    • Table of contents
    • Summaries
    • Product Description and Manufacturing (as applicable)
    • Nonclinical (if applicable)
    • Clinical -- Product Impact on Individual Health (if applicable)
    • Clinical -- Product Impact on Population Health (if applicable)
    • Environmental Impact 
  • How to Submit an EX REQ 
    • Online
    1. Request, in writing, an Industry Account Manager (IAM) to establish a CTP Portal account, if your company does not already have an IAM.
    2. Prepare your submission electronically using FDA's eSubmitter software and the eSubmitter template “CTP Transmittal Form.”
    3. Submit online via the CTP Portal.
      Note: The CTP Portal provides more functionality than the ESG, and CTP recommends using the CTP Portal. However, if you already have an ESG WebTrader account, you may use it to submit documents to CTP.
  • Amendments
    Amendments can be submitted using the above instructions.  The amendment should include a cover letter that includes the submission tracking numbers of the EX REQ in the subject line.  If responding to a deficiency (including requests), follow the instructions as outlined in your deficiency letter.   

Step 2: Submit an Abbreviated Report

  • Abbreviated Report: Step Two in the exemption process, the Abbreviated Report must be prepared after an Exempt Order is issued and is required to legally market a new tobacco product. It should include information demonstrating that:
    • The product is in compliance with the FD&C Act.
    • All modifications are covered by exemptions granted by FDA (Exempt order letter was issued).
    • The modifications are to a product that can be commercially marketed.
    • Actions taken by the manufacturer to comply with the requirements under section 907 of the FD&C Act, as applicable.

To assist FDA in the review of the Abbreviated Report, we recommend you utilize the format provided within the appendix of your Exempt Order.


EX REQ Review Process

Exemption from Substantial Equivalence
  • Acceptance Review: An administrative review that ensures the product falls under the Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirements of an application are met based upon sections 910 and 905(j)(3) of the FD&C Act, criteria set forth in  § 1107.1, and the criteria set forth in § 1105.10.
    • Output
      • Acceptance letter or
      • Refuse to accept (RTA) letter
  • Notification: FDA review process when manufacturer proposes to modify a tobacco product legally marketed under a pending provisional SE Report or RFR status.
    • Output
      • Notification letter: Notification of intent to review provisional product (e.g., pull from RFR), and suspend review of EX REQ until final determination of SE Report. Applicants have 14 days to withdrawal the EX REQ if they do not want to initiate this process.
  • Substantive Review: FDA evaluation of the scientific information and data in an application.
    • Output
      • Deficiency letter: Additional information is needed to make a found exempt decision. Applicants have 30 days to respond to this type of letter.
      • Environmental information request letter: FDA made a scientific decision to support a marketing order; however, the applicant is required to provide information for environmental considerations before a marketing order can be issued. 
  • Action:
    • Output
      • Exempt order letter 1 or
      • Not exempt order letter

Abbreviated Report Review Process (Step Two of the EX REQ process)

Exemption from Substantial Equivalence
  • Acceptance Review: An administrative review that ensures the product falls under Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirements of the Abbreviated Report are met.
    • Output
      • Acceptance letter 2
      • General correspondence letter: Provides detail if information provided does not allow for an EX REQ to be established
  • Notification:  
    • Output
      • None required
  • Review:  FDA evaluation of the information in the Abbreviated Report.
    • Output
      • None required
  • Action:
    • Output
      • None required – If the manufacturer has not received additional correspondence from FDA within 90 days, they may commercially market the new tobacco product within the United States.

Performance and Reporting


Resources


Additional Resources